Addition of microRNA Blood Test to Lung Cancer Screening Low Dose CT
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03452514|
Recruitment Status : Completed
First Posted : March 2, 2018
Last Update Posted : February 25, 2021
|Condition or disease|
This is a prospective, longitudinal, blinded, observational diagnostic study on 400 individuals undergoing lung cancer screening with low-dose computed tomography (LDCT).
There will be two patient cohorts: Cohort 1: individuals undergoing their first or subsequent annual LDCT screening study; and Cohort 2: individuals referred for a follow-up diagnostic chest CT scan due to a lung-RADS category 3 or 4 result on a previous LDCT scan.
At study enrollment a blood sample will be drawn prior to the LDCT scan. On this blood sample a novel lung cancer test relying on microRNA signatures will be evaluated. The results will be compared with the CT scan results and follow-up tests including pathology. Histologic results and follow-up data will be collected on all patients for a minimum of 12 months post-enrollment. During the follow-up period, the results of all diagnostic chest CT scans, lung biopsies or lung resections will be captured from the Partners electronic medical record and entered into the case report form (CRF).
|Study Type :||Observational|
|Actual Enrollment :||479 participants|
|Official Title:||Prospective Longitudinal Blinded Observational Diagnostic Study - Addition of microRNA Blood Test to Lung Cancer Screening Low Dose CT|
|Actual Study Start Date :||November 1, 2017|
|Actual Primary Completion Date :||September 14, 2020|
|Actual Study Completion Date :||September 15, 2020|
Cohort 1 - Low Dose CT (LDCT) Scan
Individuals undergoing their first or subsequent annual LDCT screening study
Cohort 2 - Diagnostic CT Scan
Individuals referred for a follow-up diagnostic chest CT scan due to a lung-RADS category 3 or 4 result on a previous LDCT scan
- Specificity of HMBDx microRNA Test for Lung Cancer [ Time Frame: 12 months ]The reference standard will be the combination of all available diagnostic information (LDCT, subsequent diagnostic imaging studies, biopsy results and surgical pathology results) obtained during at least 12 months of follow-up.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452514
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Lahey Hospital & Medical Center|
|Burlington, Massachusetts, United States, 01805|
|Study Director:||Amita Sharma, MD||Massachusetts General Hospital|